Managing SOP Compliance per FDA Regulations

Why Should You Attend:

Standard operating procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection.

In this webinar, participants will learn how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is reproducible and easy to follow.

Learning Objectives:

• Formatting SOPs
• Elements to include other than the procedure
• How to write effective but efficient documents
• Roles and responsibilities of authors and reviewers of SOPs
• How to define roles in SOPs for supervisors and operators

Areas Covered in the Webinar:

• Why written procedures are beneficial
• FDA expectations for written documents and regulatory requirements
• Developing an effective review and approval process compliant with regulatory requirements
• How to implement a training program for document creation and review
• A system for the control, archival, and disposal of written procedures

Who Will Benefit:

• Directors
• Managers
• Professionals
• Technical writers
• General staff with the responsibility for creating, reviewing and approving written standard operating procedures and instructions

Instructor Profile:

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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